MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number S-65-120-120-P6

Device Problems Positioning Failure (1158); Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/18/2015

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a moderately calcified lesion in the superficial femoral artery (sfa).Pre-dilatation was performed with an unspecified balloon dilatation catheter (bdc).The 6.5mmx120mmx120cm supera self-expanding stent system (sess) was advanced to the target lesion without issue; however, during deployment the stent implant could not be fully deployed.Reportedly, there was no issue with the handle or locks of the sess.Multiple attempts were made to fully deploy the stent implant; however, the proximal portion of the stent did not release.During the attempt to remove the sess delivery catheter, the stent implant was pulled/migrated completely out of the target lesion and into healthy tissue.An absolute pro stent implant was deployed to treat the target lesion.There was no reported adverse patient sequela and no reported clinically significant delay in the procedure.There was no additional information provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances related to the reported event.A query of the complaint history of the reported lot revealed no other incidents have been reported.Based on the reviewed information, no product deficiency was identified.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): WEBSTER, TX USA REG#3005325609; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4669801
• MDR Text Key: 5732599
• Report Number: 2024168-2015-01924
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: S-65-120-120-P6
• Device Lot Number: 02368069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 68